ABBOTT PARK, Ill., March 5, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced U.S. Food and
Drug Administration (FDA) Emergency Use Authorization (EUA) for the
company's Alinity™ m Resp-4-Plex molecular assay to detect
and differentiate SARS-CoV-2, influenza A, influenza B and
respiratory syncytial virus (RSV) in one test. This is an important
tool because these viruses have similar symptoms but require
different treatment approaches. This test is CE Marked and
available in countries outside the U.S.
The Alinity m Resp-4-Plex test can be conducted with one swab
specimen (anterior nasal or nasopharyngeal) collected by a
healthcare provider or an anterior nasal swab specimen
self-collected at a healthcare location from individuals suspected
by their provider of respiratory viral infection consistent with
COVID-19. Test will run on Abbott's Alinity m system — the
company's most advanced high-volume laboratory molecular
instrument. Alinity m uses Polymerase Chain Reaction (PCR)
technology, which is known for its high sensitivity in detecting
infectious diseases. To help fight the pandemic, Abbott has
accelerated placements of the Alinity m system in hospital labs,
academic centers and labs that are critical to patient care.
"Abbott has been developing and introducing tests that have been
playing a critical role in fighting the pandemic. The need for a
combination of testing methods in different settings has never been
more clear," said Andrea Wainer,
executive vice president, Rapid and Molecular Diagnostics, Abbott.
"This newest test will allow for fast and efficient diagnosis and
triage of patients who present with respiratory symptoms so they
can be given the right care."
Advanced technology's role in the fight
The Alinity m Resp-4-Plex assay will be a critical tool in
detecting these four prevalent respiratory viruses. The advanced
technology of the Alinity m system provides automation and
on-demand access, meaning an urgent test can be run at any time.
This flexibility and efficiency allow for the testing of multiple
diseases while still producing fast results in high volumes. This
assay's ability to detect and differentiate these viruses
simultaneously with only one swab will also ease the resource
strain on collection devices, which have been in high demand
throughout the COVID-19 pandemic.
Expanding Alinity m SARS-CoV-2 to asymptomatic cases
Abbott is also announcing that the EUA for the company's Alinity
m SARS-CoV-2 test has been updated to include an asymptomatic claim
– detecting COVID-19 in individuals who do not have symptoms. A
recent study found that more than 60% of COVID-19 infections
present as asymptomatic cases, which is why it's critical to catch
those cases before they spread.1 With the recent update
to the Alinity m SARS-CoV-2 test EUA, the assay can now be used to
detect individuals who are infected with SARS-CoV-2, but do not
have symptoms or other reason to suspect COVID-19 infection. The
Alinity m SARS-CoV-2 test EUA was also updated to include a pooling
claim, which allows up to five samples to be tested at the same
time. The updated Alinity m SARS-CoV-2 test, Alinity m Resp-4-Plex
assay, and Abbott's existing testing technologies will now
all be available to support front-line healthcare workers.
About Alinity m
Assays available for use on the Alinity m system worldwide
include: SARS-CoV-2, HCV (hepatitis C), HBV (hepatitis B), HIV-1
(human immunodeficiency virus type 1), STI (CT/NG/TV/MG) and HR
HPV. The easy-to-use system will help to improve laboratory
workflow and efficiency with its large capacity and fast turnaround
time, being able to run up to 1,080 tests in a 24-hour period based
on laboratory practice and workflow. Alinity m systems are designed
to be more efficient – running more tests in less time and
minimizing human errors – while continuing to provide quality
results. The availability of the Alinity m system and tests varies
by geography. More information is available
at molecular.abbott.
About Abbott
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 109,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews.
Alinity m assays: STI (CT/NG/TV/MG) and HR HPV are not
commercially available in the United
States.
The Abbott Alinity m Resp-4-Plex product has not been
FDA cleared or approved, but been authorized for emergency use by
FDA under an EUA for use by authorized laboratories. This product
has been authorized only for the detection and differentiation of
nucleic acid from SARS-CoV-2, influenza A, influenza B, and/or
Respiratory Syncytial Virus, not for any other viruses or
pathogens; and the emergency use of this product is only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21
U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
1.
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Zachary J. Madewell,
PhD., Yang Yang, PhD., Ira M. Longini Jr, PhD., M. Elizabeth
Halloran, MD, DSc., & Natalie E. Dean, PhD. (2020). "Household
Transmission of SARS-CoV-2: A Systematic Review and Meta-analysis".
JAMA Network.
doi:10.1001/jamanetworkopen.2020.31756
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SOURCE Abbott